Bioequivalence and Bioavailability Forum • BA Studies

BA Studies [Design Issues]

posted by sushilsingh – 2007-08-27 08:07 (6883 d 03:20 ago) – Posting: # 1024
Views: 5,682
(edited on 2007-08-27 11:10)

Can anyone perform BA studies under ANDA kind of scenario. For eg if we want to test the bioavailability of five test formulation (single period BA study on 30 vol.) to check which one is giving better profile. Subsequently the best two will be picked up for conducting routine BE pilot study. What is the rationale (ethical as well as scientific) of this kind of study. Provide your expert comment on it.

[edit] Capitals changed to mixed case. Please read the forum policy/instructions for use ! [Ohlbe]

Complete thread:

BA Studiessushilsingh 2007-08-27 06:07
- Parallel groups "pilot pilot" study Ohlbe 2007-08-27 11:17
  - Parallel groups "pilot pilot" study sushilsingh 2007-08-27 14:18
    - Parallel groups "pilot pilot" study Ohlbe 2007-08-27 14:45
    - Quite unusual design... Helmut 2007-08-27 14:57
      - Ethical issue sushilsingh 2007-08-28 14:26